Animal Drug User Fees and Fee Waivers and Reductions; Draft Revised Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #170 entitled "Animal Drug User Fees and Fee Waivers and Reductions." This draft revised guidance document describes the types of fees the Food and Drug Administration (FDA or the Agency) is authorized to collect under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, and how to request waivers and reductions from these fees.